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The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation). These devices will be evaluated at approximately 3, 6 and 12 months with 3 scoring criteria: Constant score, VAS pain score, and subjective shoulder value score (SSV). At the 6-month and 12-month post-operative visit, tendon healing, and the absence of recurrence of rupture or failure to heal in patients treated with lok™ anchors will also be analyzed.
The Sugaya score on ultrasound imaging will be used for this assessment. Adverse Events (AEs) and Serious Adverse Events (SAEs) will be assessed after the surgery and at each follow-up (1, 3, 6 and 12 months after the surgery).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Move-Up arm | Experimental | lok™ suture anchors range and associated instrumentation |
|
| Routine care | Active Comparator | Anchors and Ancillairies already CE marked (control arm) and used in routine care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotator cuff lesions repair combined to a long head of biceps pathology | Procedure | Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion), |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant score | The functional improvement related to the implantation of these devices will be at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days with the primary endpoint being the Constant score. | From enrollment to the final follow up at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Evaluate the evolution of pain: This will be assessed using the Visual Analog Scale (VAS) for pain at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days. | From enrollment to the end of follow up at 12 months |
| Adverse Events (AEs) |
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Inclusion Criteria:
Consent to participate in the study: oral and written.
Man or woman over 18 years old with bone maturity finished.
Presented with one of the following indications:
MRI or arthrogram proving the rotator cuff lesion and long head of the biceps tendon injury, or the labrum injury, or PASTA injury.
Non inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manal OUBOUKHA, Clinical affairs manager | Contact | 33 677 096 697 | manal.ouboukha@move-ortho.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alixan | Recruiting | Valence | Auvergne-Rhône-Alpes | 26300 | France |
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| PASTA lesion | Procedure | partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair |
|
| Shoulder instability repair | Procedure | Gleno-humeral instabilities (Bankart lesion, SLAP lesion) |
|
Evaluate the safety of the lok™ system: Adverse Events (AEs) related to the devices will be collected at any time from the start of inclusion until 12 months after surgery. |
| from enrollment to the final follow up at 12 months |
| Subjective Shoulder Value (SSV) | Evaluation of the patient's subjective value with the Subjective Shoulder Value (SSV) at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days. | From enrollment to the final follow up at 12 months |